Process for Use of SDTM Submission Planning Template for ...
eCTD Guidance; Study Data Specifications, Version 1.3. l. General folder structure: m. Specify format of submission files: n. Method of delivery to FDA: CDs (Compact Discs) 2. Information Pertaining to Submitted CRFs . This section should include information on how Case Report Forms are submitted as required by 21 CFR 314.50(f)(2). ................
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